FDA Clears Clinical Trial of NK010 in Ovarian Cancer

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NK010 represents a promising advancement in the landscape of natural killer cell-based immunotherapy across a variety of cancer types.

  • NK010 is a novel non-genetically modified natural killer (NK) cell therapy.

  • In vivo models have shown significant tumor growth inhibition with NK010 across a variety of solid tumors, as well as acute myeloid leukemia (AML).
  • Ongoing clinical trials will further evaluate NK010 and its potential impact on cancer treatment and in non-tumor settings.

The FDA has granted clearance for a clinical trial of NK010 for the treatment of specific cancer types, particularly those that are resistant to established therapies, according to NK CellTech.1 The first indication selected for investigation in the clinical trial is ovarian cancer.

NK010 is a novel non-genetically modified NK cell therapy. This is the first non-genetically modified NK cell therapy that comes from allogeneic peripheral blood cells (PBMC) to be approved for clinical trials by the FDA from China.

The therapy utilizes non-genetically modified NK cells extracted from healthy donor PBMCs and demonstrates a comprehensive antitumor profile through broad spectrum activity by expressing activation receptors which enable potent targeting of diverse tumor types and enhanced potency. The high purity of NK010 ensures a concentrated arsenal of cytotoxic NK cells.

"We are thrilled and proud to receive FDA clearance for the clinical trial of NK010," said Zhigang Tian, professor, founder of NK CellTech and member of the Chinese Academy of Engineering and the Academia Europaea, in a press release. "NK010 has demonstrated promising antitumor activity and safety in preclinical studies.”

Ovary under the microscopic: © sinhyu - stock.adobe.com

Ovary under the microscopic: © sinhyu - stock.adobe.com

In preclinical trials, NK010 demonstrated remarkable tumor-suppressing prowess against ovarian cancer, liver cancer, and other solid tumors. The agent also showed strong tumor growth inhibition on AML.1,2

NK010 also shows the potential to treat multiple other types of diseases, including non-tumor diseases. Further, its high purity and effectiveness make it an ideal starting point for the company's next-generation synthetic NK cell drugs.1

NK010 represents a promising advancement in the landscape of NK cell-based immunotherapy. Ongoing trials will further evaluate its potential impact on cancer treatment and explore its utility in non-tumor settings. Now, a phase 1 clinical trial will evaluate NK010 in patients with a variety of cancer types, focusing first on patients with ovarian cancer.

“We have great confidence in its potential to treat solid tumors. Yet, there is still a lot left to explore, and our team has remained on our mission to revolutionize cancer treatment through innovative cellular therapies and fulfill the unmet clinical needs in the future," added Tian, in a press release.

REFERENCES:
  1. NK CellTech announces FDA clearance for clinical trial of NK010. News release. NK CellTech. January 22, 2024. Accessed January 22, 2024. http://tinyurl.com/2b4khsyb
  2. NK CellTech. Pipeline. Accessed January 22, 2024. https://www.nk-celltech.com
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